Acronym

REALISTIC

Study hypothesis

Human Papilloma Viruses (HPVs) are obligate human pathogens, some have the propensity to promote malignant transformations of their host cells. An example of this is HPV-16 in the oropharyngeal squamous cell carcinoma, which is seen in about 50-70% of cases although there is geographical variation.

Oropharyngeal squamous cell carcinoma (OPSCC) is on the increase in Europe and the United Kingdom, Cancer Research (UK) reported 953 new cases in 2005. If we accept that approx. 40-50% of these new cases may be due to HPV-16 infection, the resultant disease burden is about 380-480 new cases per annum in the UK. In contrast to other head and neck cancers, HPV related OPSCC occurs in younger patients, who are non-smokers and non-heavy drinkers.

If proved safe, there is a role for ADXS11-001 as a post-treatment adjuvant as part of a treatment de-escalation strategy in an attempt to reduce the adverse effects of current treatment strategies without compromising survival.

The REALISTIC trials' objective is to determine safety and to characterise the toxicity profile of ADXS11-001.

Ethics approval

First MREC, 20/09/2011, ref: GTAC 176

Study design

Non-randomised interventional screening treatment

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Head and neck cancer

Intervention

ADXS11-001 - the patient will recieve 3 vaccinations. The vaccine will be given on Day 1 of each cycle. An interval of at least 28 days should occur between any two vaccinations. To proceed to the next vaccination the previous vaccination(s) must have been well tolerated. At each recruiting centre, the infusion will take place in an area specifically designated for phase I clinical trial patients to receive their experimental treatments. Follow Up Length: 12 months

Overall trial start date

Overall trial end date

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Histologically confirmed HPV-16 +ve, p16 +ve OPSCC2. Patients in remission from disease, i.e. complete response (CR) or unconfirmed complete response (CRu) in the case of non-surgical treatment or complete macroscopic resection of tumour and associated cervical lymph nodes in patients undergoing surgery3. Completion of standard therapy for malignancy at least 6 weeks before trial entry4. A positive result following anergy testing5. Written informed consent and the ability of the patient to co-operate with treatment and follow up must be ensured and documented6. Age greater than 18 years7. World Health Organisation (WHO) performance status of 0 or 18. Life expectancy of at least 12 months9. Haematological and biochemical indices (these measurements must be performed within 8 days prior to the patient going on study)10. Haematological:10.1. Haemoglobin (Hb) > 10.0 g/dl10.2. Neutrophils = 1.5 x 109/L10.3. Platelets (Plts) = 100 x 109/L11. Baseline liver function tests:11.1. Serum bilirubin = 1.5 x upper normal limit11.2. Serum alkaline phosphatase, alanine amino-transferase (ALT) and/or aspartate amino-transferase (AST) < 1.5 x ULN12. Baseline renal function test: calculated creatinine clearance > 50ml/min (uncorrected value) or isotope clearance measurement > 50ml/min13. Female patients of child-bearing potential are eligible, provided they have a negative serum pregnancy test prior to enrolment and agree to use appropriate medically approved contraception during the study up to six months after the last vaccination14.. Male patients must agree to use appropriate medically approved contraception during the study up to six months after the last vaccination15. Lower age limit 18

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 36; UK Sample Size: 36

Participant exclusion criteria

1. Receiving, or having received, chemotherapy or radiotherapy within 6 weeks of trial entry.2. Having undergone surgery +/- PORT within 6 weeks of trial therapy3. A negative result following anergy testing4. Known chronic active infection with Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV)5. Current active autoimmune disease6. Current active skin diseases requiring therapy (psoriasis, eczema etc)7. Ongoing active infection8. History of anaphylaxis or severe allergy to vaccination9. Previous myeloablative therapy followed by an autologous or allogeneic haematopoietic stem cell transplant10. Patients who have had a splenectomy or splenic irradiation, or with known splenic dysfunction11. Receiving current immunosuppressive medication, including corticosteroids within 4 weeks of the first dose12. Pregnant and lactating women13. Ongoing toxic manifestations of previous treatment14. Major thoracic and/or abdominal surgery in the preceding four weeks from which the patient has not yet recovered15. Patients with any other condition which in the investigator's opinion would not make the patient a good candidate for the clinical trial16. Concurrent congestive heart failure or prior history of class III/ IV cardiac disease

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

Updated 04/04/2016: This trial closed early after one person had developed a serious infection caused by the vaccine and the company who makes the vaccine decided not to continue supplying it for the study.